The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Ambuvac.
| Device ID | K971548 |
| 510k Number | K971548 |
| Device Name: | AMBUVAC |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KINETIC CONCEPTS, INC. 3440 EAST HOUSTON ST. San Antonio, TX 78219 |
| Contact | William H Quirk |
| Correspondent | William H Quirk KINETIC CONCEPTS, INC. 3440 EAST HOUSTON ST. San Antonio, TX 78219 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-28 |
| Decision Date | 1997-05-22 |
| Summary: | summary |